Events

Recall of Cobas c 501 / c 502 and COBAS INTEGRA. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00229-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00229-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Following customer complaints regarding a 20% decrease in control levels when using third party controls (e.G. thermofisher liqimmune) roche has identified that reagent lot 697811 shows a negative bias of up to 54% compared to lot 604303.This negative bias could, in the worst case, lead to inaccurately low homocysteine results.This issue only occurs with edta plasma samples.
  • Action
    Roche is requesting their customers to discard any remaining units from the affected lot. This action has been closed-out on 18/08/2016.

Device

Cobas c 501 / c 502 and COBAS INTEGRA. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Cobas c 501 / c 502 and COBAS INTEGRA. An in vitro diagnostic medical device (IVD)Material Number: 05 385 415 190Affected lots: 69781101Expiry Date: 30 Apr 2015Subsequent lots: 60717101Expiry Date: 31 Jan 2016
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited